Data Foundry

Medical device recalls 2026

AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1)… — Class II medical device recall Z-2813-2026

Ongoing recall by Windstone Medical Packaging, Inc., reported 2026-08-05, distributed nationwide. Windstone Medical Packaging recalled specific items and lots of AMS convenience kits containing Elevaris Lidoc

Recall numberZ-2813-2026
Product typeMedical device
ClassificationClass II
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmWindstone Medical Packaging, Inc., Billings, MT, United States
Recall initiated2026-06-17
Classified2026-07-27
Reported by FDA2026-08-05
DistributedNationwide (US)
Quantity580 kits
Lot numbers216803, 217313, 229846, 230645, 230948, 230958, 231043, 231078, 231238, 240843, 241232
Model numbersAMS1095, AMS11296A, AMS11314A, AMS11910A, AMS12171, AMS12219A, AMS12381B

Product

AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) Dr Fred Chiu Single Shot Epi Tray - Rx, Part Number AMS1095(E ; 2) Single Shot Epidural Tray - RX, Part Number AMS11296A; 3) Nerve Block Tray - RX, Part Number AMS11314A; 4) Epidural Tray - RX, Part Number AMS11910A; 5) Nerve Block Tray - RX, Part Number AMS12171; 6) Single Shot Epidural Tray - RX, Part Number AMS12219A; 7) Universal Block Tray - RX, Part Number AMS12381B.

Reason for recall

Windstone Medical Packaging recalled specific items and lots of AMS convenience kits containing Elevaris Lidocaine HCl injection USP. Elevaris Medical Devices Inc. recalled the Lidocaine HCl injection USP due to supplier quality issues.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2813-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.